GAMP® 5

This article explores life-cycle activities for machine learning (ML) within regulated life sciences. It positions and contextualizes the life cycle and management of the machine learning subsystem or components within a wider system life cycle. It also gives general descriptions and guidance illustrated by a case study demonstrating a machine learning application to medical image recognition, or software as a medical device (SaMD).

IT Services: Applying Good IT Practice and Automation Cover: This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure...